Year: 2020

Posted on by

Top Life Sciences Industry Trends To Watch For in 2021

blue dna

The life sciences industry is the umbrella term for companies, businesses, and research institutions dedicated to improving protection and improvement of human, animal, and natural life. It includes cell biology, biophysics, environmental sciences, biomedicine, pharmaceuticals, biotechnology, nutraceuticals, neuroscience, and countless others. As you might imagine, this is a frontier that moves rapidly, constantly driven by change and technological advancements.

Looking ahead to 2021 indicates that the following trends will play a key role in shaping the life sciences industry:

Personalized medicine through advancements in genetics

As researchers continue to discover the genetic coding component of some conditions, the possibilities for personalizing medicine and healthcare procedures based on each person’s particular DNA information or other genome features become greater and more exciting.

Collaborative Innovation of Various Life Sciences Companies

In May of 2019, Arzeda, Twist Bioscience, Labcyte, and TeselaGen joined forces to create a state-of-the-art assembly platform for the DNA molecule. This is just one example of how highly collaborative the life sciences industry is, and what the possibilities are when health science organizations work together to push the boundaries of research and development.

Advancement of Drug Research

Smart technology will allow for better integration of data from assessment devices such as patient monitors, laboratory equipment, and MRI scans to more accurately prescribe medication for patients for more objective, evidence-based results.

Increased Volume of Life Sciences Research

In the field of precision surgery, studies connecting robotics to improve surgical methods are on the rise. Artificial intelligence can provide doctors insight in the most accurate treatment plans and which procedures will result in the best outcomes.

Increased Digitized Assessment, Diagnosis, and Treatment of Patients

Digital transformation has paved a way for better consumer access and improved marketing strategies for companies. The life sciences industry is expected to see an increase of digitalization through online assessment, diagnosis, and treatment of patients in 2021.

Value-based Pricing of Products

As more laws are being passed to drive down the prices of products especially in the pharmaceutical and nutraceutical industries, more companies will continue to work hard to demonstrate a drug’s effectiveness so that consumers can see the true value of the product. This can help drive down the cost of medications while providing evidence-based information for people to whom the drug’s efficacy matters most.

Data Management and Integration

Continued innovation of and improvements to cloud management strategies will enable data analysts to more easily gather, organize, and interpret information that is pertinent for life sciences research and system operations.

Incorporation of Genetics in Treatment

Expect more integration of genetic information into the assessment and treatment of disorders. In time, gene technology will make it possible for researchers to identify genome sequences that can predict disorders in humans and animals.

Heightened Focus on Immune Cell Function

A better understanding of immunity will inform how diseases and viruses are spread—especially important in light of the recent pandemic. Researchers are interested in certain attributes of cells demonstrated to be immune to certain types of viruses and bacteria. These studies will bring about profound implications in the field of immunotherapy.

Trends that are expected to affect the life sciences industry in 2021 are exciting and ever changing. Countries including the United States have increased funding in the research areas of science, technology, and healthcare, demonstrating the world’s commitment to innovations within the life sciences industry. Continued innovation and advancement will improve the welfare of those of us who are living today, as well as those for generations to come.

Posted on by

Laboratory Relocation Tips For Success

cold storage units and researcher in lab
Whether you’re renovating, consolidating, decommissioning, or expanding your laboratory into a brand new space, use a detailed transition plan to ensure a smooth move and protect your projects. After all, the stakes are high– and missteps have the potential to cause more than temporary inconvenience – so be sure to pay close attention to every detail.

The process can be so complex that some labs hire “transition planners.” Using a set of proprietary templates, checklists, and work plans, these professional planners forecast a timeline for the entire transition, day by day, complete with all the decisions and activities that will need to be made. If you’re anticipating a lab relocation, consider whether or not to hire a transition planner in light of the following points:

Expertise.

Believe it or not, some laboratory transitions take up to six months of planning before a single piece of equipment is moved. With that level of detail to consider, even if you feel you have the resources in-house, you may want to hire an experienced professional planner dedicated to this one task only. This will allow your research staff to continue working on their projects virtually uninterrupted, while your transition planner manages the logistics of the upcoming move.

Experience.

It bears repeating because it’s the most critical thing to account for when managing a laboratory relocation: maintaining the integrity of ongoing research is the most important aspect of any transition. This means your transition planner needs to fully understand the environment your lab is moving into. Where will each piece of equipment be located? Is the proper electrical, mechanical, and plumbing infrastructure in place? If you deal in live specimens, what sort of climate and humidity controls need to be implemented?

The following 10 best practices are highly recommended when transitioning your lab:

Choose Your Internal Team.

It’s likely everyone will play a role, but selecting key people to act as team captains will help keep things on the rails. At your first meeting, identify important dates and a project timeline that you can share with the rest of the staff. Set up regular meetings with your core team so everyone stays informed and any emerging issues can be nipped in the bud before they become problems.

Find a Qualified Equipment Mover.

Don’t rely on regular home or business moving companies to handle your sensitive lab equipment. We don’t have to tell you that these items are delicate and easy to damage. Spend the money and hire someone who specializes in moving lab equipment– the extra investment is well worth it.

Monitor Calibration of Instrumentation.

Talk to your vendors/service contractors to determine under what conditions they will calibrate your equipment after your move. Will they recalibrate or re-certify instrumentation after the move, or does your Agreement with them require that they crate, pack, move and uncrate the equipment in order to maintain your indemnification and guarantee?

Determine Cold Storage Needs.

A regular freezer truck probably isn’t going to do it if you are moving items that require cold storage. Any laboratories contain items, samples, or substances that must be kept in cold storage. Factor in the exact temperature ranges and requirements that the items involved in your research require. Have a back-up freezer on hand the day of the move. Dry ice is also a good idea “just in case.” T

Observe the Chain of Custody.

Do you handle evidence for law-enforcement agencies? Pay particular attention to documenting any chain-of-custody considerations during transport.

Special Permits for Hazardous Materials.

Chances are your lab uses items classified by the Department of Transportation (DOT) as hazardous. Make sure you’re adhering to any legal requirements as well as safety concerns while in transit.

Avoid Cross-Contamination.

Your lab’s reputation is on the line. Take every step to ensure that the outcome of your future research is scientifically valid by being accurate and thorough with every item in your lab. Live animals are a special consideration.

Comply with GMP Requirements.

The need to meet regulatory compliance requirements (especially GLP/GMP guidelines) both before and after relocation– is essential. You will need to fill out and file all the appropriate documentation, which can be extensive– so be sure you do your due diligence very early in the lab relocation process.

Plan Your Route.

You may find that doorways and corridors are not large enough to accommodate bulky lab equipment. Measure equipment and consider your route carefully– find alternatives if you have an issue.

Anticipate Your Needs.

Replacing the benches at your new lab? Make sure they look more than look great. If they won’t bear the weight of tabletop equipment, you’ll have big problems on your hands. How about electric outlets and cord lengths? Again, these issues are easy to address in advance, but very inconvenient the day-of.

The most important thing to remember is that laboratory relocation is never routine. The process is complex and the stakes are high. So whether you hire a transition planner, appoint someone from inside your organization, or take the job on yourself, pay careful attention to the details by using these suggested best practices as your guide!

Posted on by

What You Need To Know Before Moving Your Laboratory

scientist working in a lab
Relocating your lab safely and efficiently can be complicated, time-consuming, and labor intensive. You may be aware of the obvious things that need to be done, like packing and labeling chemicals and other items on the shelves, transporting them safely to their new location, and decontaminating everything thoroughly when you’re down to the bare walls.

However, you should be aware of a few less obvious things. You need to be performing all these tasks according to the compliance and regulatory issues from the EPA, OSHA, DOT, IATA, and any other regulatory bodies that pertain to your laboratory relocation.

Therein lies the $64,000 question: which regulatory guidelines apply to you based on the size of your lab, the work you do, and multiple other factors? In some circumstances, ignoring any required steps could cause employee injury or property damage, and result in thousands of dollars in fines…but not all circumstances. To make it clear to you which regulations and compliance measures apply to the relocation of your lab, and to ensure a safe relocation of your lab according to all the pertinent compliance measures and regulations, it makes sense to reach out to your local regulatory bodies to ask what’s expected of you during your move. Hiring an experienced partner like BaneBio to consult on the logistics of the project could prove to be one of the most helpful things you can do to save time while keeping the project compliant.

Financial Management

Depending on the size and distance of the move, lab relocations can be costly. Rather than hiring a different contractor for each step, a good way to cut costs safely is by hiring one contractor to go through the entire process with you. This will improve the efficiency of the project and decrease the overall price.

Hiring and Team Management

Your logistics consultant will help you assemble the appropriate relocation team based on the size and particulars of your lab. You may need to assemble a team made up of experts in all aspects of a lab relocation that represent key internal and external stakeholders, including team leaders, environmental consultants, project managers, and supply chain vendors.You may not need a team like this, but your logistics consultant can help you determine an alternate way to stay organized and on track during your relocation.

Waste Disposal

Rely on the knowledge of either on-site team members or logistical consultants who have a deep knowledge of hazardous waste disposal. To reduce liability, you will want to dispose of unnecessary hazmat rather than transport it. Assess all chemicals prior to transportation, and dispose of any that will not be used at the new facility.

Hazmat Transportation

Despite your best efforts, it is likely that some hazmat will need to be transported during a lab relocation. If your logistics consultant advises, be sure to adequately pack, label, and transport hazmat all within PHMSA regulations.

Lab Decontamination

It is standard practice to decontaminate the facility you are vacating according to ANSI guidelines. Again, your logistics consultant can advise you on appropriate decommissioning methodology based on the work you have been doing.

Sampling and Reporting

Once again, if advised by your logistics consultant, qualify and document the decontamination of the lab you are vacating through sampling and reporting using real time sampling as well as laboratory analysis. Summarize the decontamination methodology, activities, and sampling results into a report that your company can use to demonstrate and quantify your decontamination efforts.

Considering a lab relocation? Unsure which compliance guidelines and regulations apply to you? BaneBio can help!

Posted on by

Choosing the Right Incubator for Your Lab

The CO2 incubator is a critical piece of lab equipment designed to create and reliably maintain a sterile, pH-optimized, humidified, in vitro environment for the culture of living tissues or cells. 

There are two main types of incubators: direct heat and water jacket. In order to determine which type of incubator best suits your needs, it’s important to review and evaluate the advantages and drawbacks of each. Because different cell types respond differently to temperature fluctuations, hypoxia, and vibrations, it is also critical to review your choices of incubator in light of which types of cells you plan to incubate, and where you plan to place the incubator within your lab. 

Once you have determined the ideal living conditions for your cells, and where the incubator will be placed within your lab, use the five considerations below to choose the right incubator for your needs:  

Know the advantages and drawbacks of direct heat vs. water jacket incubators.
A water jacket incubator has a water-filled layer, or “jacket”, surrounding the growth chamber. The water within the jacket circulates, creating a relatively uniform interior temperature and thermal buffer against outside air fluctuations. Because water jacket incubators can hold heat up to five times longer than direct heat units, they are especially advantageous in the event of a power outage. A water jacket also reduces vibrations, which is valuable when you are working with sensitive cells. 

Keep in mind, however, that water jacket incubators are very heavy when filled, and can take up to 24 hours to reach a stable operating temperature. Also, because they are not designed to operate at temperatures high enough to sterilize or decontaminate, gas decontamination may be required.

Like water jacket units, direct heat incubators also heat the inner chamber through conduction; however the inner walls of the unit have direct contact with heating coils instead of the water jacket. This results in more rapid temperature changes. Rather than the 24 hours a water-jacket unit takes to reach required temperature, setup of a direct heat incubator takes only eight hours. Its heating coils can also reach temperatures to sufficiently sterilize and decontaminate. 

On the other hand, because the direct heat incubator’s heating coils have very specific contact points on the inner walls, the inner chambers of this type of incubator are less uniformly heated and are more susceptible to changing ambient air temperature and temperature fluctuations. When temperature stability is critical, a water jacket incubator may be more suitable for your needs.

Determine where within the lab the incubator will be located.
Because the environment that surrounds the incubator affects the way it functions, determining where the unit will be located is important before you make a decision. A water jacket incubator works best in a “hot spot” or if the ambient temperature of the lab changes frequently. The water conduction system is significantly more resistant to external temperature changes than are the coils of a direct heat incubator. If the incubator is to be placed near equipment that vibrates heavily such as a centrifuge, a water jacket unit will minimize this movement. 

Assess the humidity controls of the incubator.
The ability to maintain the ideal humidity within the incubator is critical because it prevents evaporation from the cell culture. When water evaporates from the media, the concentration of amino acids, salts, and metabolites spikes, causing osmotic pressure to rise and subsequent damage to cells. Regulating the amount and type of airflow that occurs within the chamber also affects the rate of evaporation. Some incubators have introduced systems to slow the airflow to minimize evaporation and avoid drying out cell cultures. When comparing incubators based on this feature, look for the number of air exchanges over time within the inner chamber.

Decide if hypoxic control is necessary and determine accuracy of gas sensors.
Preserving a healthy level of carbon dioxide within an incubator is important because the interaction of CO2 with the cell culture media determines the media’s pH. Many incubators use conventional thermal conductivity (TC) sensors, but newer models rely on a type of infrared (IR) sensor that is less sensitive to chamber humidity and temperature. 

Oxygen levels can also have drastic effects on the growth of some cultures such as stem cells or primary tissues. An incubator with O2 controls uses nitrogen gas to lower the concentration of O2 within the growth chamber. Evaluating the need in your lab for this type of gas control measure is an important consideration when purchasing an incubator.

Consider options for constant contamination control.
Contaminants can be entered into the incubator simply by opening the door. When an incubator is maintained with positive pressure within the growth chamber, airflow into the chamber is minimized—preventing airborne contamination. Internal air is then forced through a HEPA filter to provide an extra layer of sterilization. 

Note that a HEPA filter installed inside the growth chamber can be problematic, especially if the blower’s motor stops, causing contaminants from the filter to fall on your cultures. Consider an externally mounted HEPA filter for easier service and repair, and to protect cells from potential contaminants. If sterility of cultures is a top priority, be especially mindful of an incubator’s contamination controls prior to purchase. 

A well-designed, properly functioning laboratory often includes incubators to keep cells growing well and protected from contaminants. Taking the time to assess your needs in light of these five considerations will help you make an appropriate choice.

Posted on by

Your Laboratory Equipment: Why a Contract Service Agreement Just Makes Sense

laboratory equipment preventative maintenance
No matter what your core business is, you need the right tools in good working order to deliver accurate results on time and on budget.

Never is this more evident than inside a laboratory. Having the right equipment—and keeping it running smoothly and calibrated accurately—is what makes it possible for your staff to do their jobs.

Fortunately, unlike some of the challenges laboratories have dealt with in the past six months, controlling downtime due to faulty instrumentation is one factor that affects your business that is within your control as a lab owner or manager.

There are four reasons why contracting with an experienced industry partner for an ongoing laboratory service agreement makes sense for you as a lab owner or manager:

1. Mitigates Downtime

First and foremost, if your equipment isn’t working, your lab’s productivity grinds to a halt. When your instrumentation is down, your staff can’t work. Having your equipment properly maintained on a regular basis is the most effective way to fix that. Knowing your instrumentation is being evaluated and maintained by a service contract team will enhance your team’s performance, mitigate downtime, and give you peace of mind.

2. Reduces Costs

With your lab instrumentation and equipment as with so many other things, an ounce of prevention is well worth a pound of cure. When you have periodic, regular maintenance through a service agreement, it is much more likely that problems with your equipment will be caught and addressed before they turn into larger issues. Letting one of these issues with your instrumentation go unheeded and unaddressed can take a big toll on your productivity, compromising your production schedule and deliverables. And if any of your lab equipment needs to be repaired, your service partner will be available to fix it—and that means you can manage your timelines better, meet your deadlines, and keep costs under control.

3. Allocates Resources Effectively

Are you currently relying on your bench scientists to keep their own equipment running well? While it may be true that some of your staff have the skills and experience needed to maintain and calibrate their lab equipment, does it make sense to ask them to? Assigning these more routine maintenance and repair tasks to a team of experts whose only job is to keep your equipment in good working order will allow your team to focus on the higher level of tasks you hired them to do.

4. Saves Time

Having a single point of contact when you need equipment maintained or repaired will save you from the lost time that results from having to manage different vendors and various maintenance schedules for each of your departments. A contract service agreement simplifies this often-complex administrative process and gives you and your team more time to focus on accomplishing the deliverables and other tasks at hand.

When you contract with an experienced and reliable service partner, you will have the assurance that your investment in your equipment and instrumentation is being protected properly. In addition to having the peace of mind that your assets will be in top working order when you need them to be, you will be able to mitigate downtime, reduce costs, allocate your resources more effectively, and save time—all important strategic advantages that your lab can leverage to benefit your laboratory operation and results.

Posted on by

How COVID-19 Is Impacting Lab Operations

scientists talking at a laboratory table
The unemployment rate in the United States is currently hovering around 15%, the worst since the Great Depression. Women, Hispanics, and African Americans have been especially hard-hit and employment in the hospitality and retail sectors has also seen a sharp decline. According to a study conducted in April by market research firm BioInformatics, a partner of The Science Advisory Board, scientists and researchers are also concerned about what the immediate future holds for their employment outlook.

Of the 1,178 participants in the BioInformatics study, 74% were academic researchers and 26% were pharmaceutical or biotech scientists. On a regional basis, 33% of participants were based in North America, 31% in Europe, 24% in Asia, and the remaining 12% were from various other locations around the world.

Although many scientists are classified as essential employees, there are many who are not— and whose livelihoods have been adversely affected during the last 2–3 months by state and local stay-at-home orders. Following the trend set by the U.S. National Institutes of Health, many programs classified as non-essential have been temporarily shut down. In addition, many scientific researchers rely on grants to conduct their research— a funding source that has been all but curtailed during the quarantine. Many researchers have indicated that funds previously used to fund their ongoing studies have been diverted to maintain current animal studies and to pay core staff.

Today, approximately three months from the initial stay-at-home orders, many labs remain closed. The situation has especially dire implications for academic scientists, only 10% of whom responded that their labs were fully operational. More than 56% of academic laboratories remain affected— many more than pharmaceutical or industry laboratories, 27% of which are still closed. Of the remaining 612 labs that are partially or fully operational, 32% conduct research related to infectious diseases, compared with 68% that are not involved in infectious disease research. Surprisingly, a full 71% of research labs dedicated to infectious disease research report running at reduced capacity.

The productivity of those labs who have remained open has been adversely affected by physical distancing and other public health measures put in place to slow or minimize the spread of the highly contagious coronavirus. Unlike many industries who have been able to stay connected through video conferencing platforms like Zoom and GoToMeeting, this alternative has been far less effective in sustaining the collaborative efforts of scientists and researchers engaged in multidisciplinary projects

In April, according to the rating scale on the initial survey, scientists indicated that their work had been severely affected by the COVID-19 pandemic. A significant number of survey participants indicated that a severe economic downturn directly resulting from the outbreak would limit their ability to work. When broken down by research focus, infectious disease researchers working at operational labs reported slightly less concern over their ability to work than did their colleagues at academic labs or those involved in other types of research.

Very few areas of modern life have remained untouched by the pandemic, and the livelihoods of scientists and researchers are no exception. However, despite their current concern about how the pandemic and related economic crisis will affect their employment in the short-term, most expect to get back to conducting their research after the crisis passes. According to the recently updated U.S. Bureau of Labor Statistics’ Occupational Outlook Handbook, updated last September, epidemiologists, medical, biological, and clinical laboratory technologists and technicians, biochemists and biophysicists, microbiologists, and medical and research scientists are and will continue to be among the fastest-growing jobs between now and 2028.

Posted on by

How The Life Sciences Industry May Look After COVID-19

scientist holding test tube blood sample

Almost every aspect of our personal and professional lives has been retooled. When it comes to the economy, a slowdown of epic proportions has already begun. How will the days, weeks, and months ahead affect the life sciences industry? Analyzing how life sciences companies have fared though the past three recessions reveals some encouraging news.

It’s important to realize that, unlike the vast majority of businesses, the core business of life science companies is more in-demand than ever before. This is good news for the individuals who work for life sciences companies, as well as the vast network of businesses—like BaneBio and many others—that support them.

The savings and loan crisis of the early 1990s, the post-9/11 dot.com bust, or the Great Recession of 2008 and beyond give us a context for how life sciences companies perform in the face of economic crisis. If the steadiness performance of the industry during the severe economic downturns precipitated by these events are any indication, life sciences businesses are in a good position to continue to serve the marketplace well in the foreseeable future.

Some Good News

History would appear to indicate that the life sciences industry is less affected by market fluctuations than other types of businesses during periods of recession and/or economic slowdown.
• Following the savings and loan crisis in 1991, transactions negotiated within the life sciences environment grew 54%; that volume decline by an average of 2.4% for all other sectors.
• In 2001 after the attack on America, transactions within the life sciences arena grew by 18%, while our colleagues in all other businesses suffered a decline in deal volume at the rate of 32%.
• During the Great Recession of 2008, the life sciences industry’s deal volume declined by 25%, still an improvement over the 30% decline in deal activity for all other sectors.

As we stare down the barrel of the current pandemic, history would indicate that several factors are likely to at least partially insulate the life sciences industry from disastrous losses.

First, biopharmaceutical companies will continue to produce medications at a similar or better rate as in the pre-COVID world. Chronic disease and acute illness will proceed unchecked by the presence of coronavirus, necessitating steady if not accelerated production of drugs used in their prevention and treatment.

Secondly, and perhaps more importantly, while most in the business world are impaled on the horns of the coronavirus dilemma, those of us in the life sciences cohort are firmly engaged in finding some of the most important solutions of our time. Our collective focus is on supporting rapid diagnostic testing, better treatment, and eventually the development of a safe and effective vaccine.

Three Areas of Concentration

There is no instruction manual for handling the current and long-term effects of the pandemic on global trade and commerce. However, early indications are that life sciences companies should mitigate the impact of the COVID-19 pandemic in three ways:

Manage the Change

Despite the continued demand for the service of the life sciences cohort, the way services are delivered will continue to be very different. As many have already experienced, the impact on your workforce as employees try to set priorities, stay focused, and manage their production schedules and deliverables while working remotely is significant.

Whenever possible, the challenge for leadership will be to get out in front of issues, creating policies and procedures that work well for your shop rather than reacting to news as it happens. How will you configure your workspace if physical distancing requirements are relaxed to allow partial or limited reopening? Will you test your employees daily? How will you ensure that communication among team members sharing responsibilities and goals is seamless and effective?

Meanwhile, pharma companies are feverishly checking their medicinal archives for anti-viral activity related to COVID-19 using innovative combinations. In parallel, diagnostic companies are racing to get rapid tests approved and scaled up, working through private-public partnerships. Medical supply manufacturers and distributors are scrambling to avoid backlogs and get personal protective equipment and medical supplies to healthcare professionals who are in dire need.

Look Ahead

Several months into the pandemic, the changes it has driven have given us both insight into its current effects on our businesses and a window into the future. Use this time to analyze and evaluate the measures taken to manage the effect the pandemic has had on your business. Leverage that insight to design and implement a more long-term plan that includes both an extended period of illness and closure and the things you are likely to encounter in the post-COVID 19 world. Are there, or will there be, opportunities that did not exist before? Identify these and act accordingly.

Revamp Your Business Plan

Building on the previous suggestion, a post-COVID world is likely to offer opportunities that were unavailable just last year, especially to small and mid-sized companies. On the other hand, we will have learned lessons from the experience that wise business owners and CEOs should bring to bear on future planning, including:

• Review Your Contingency Planning: You know that employee in Accounting who was always advocating keeping a higher percentage of revenue in reserve for a “Rainy Day”? Even if you couldn’t agree with their abundance of caution before, history has proven them right. Having significant reserves for the unthinkable has turned out to be very prudent. Instead of going through cursory “in case of emergency” financial exercises, consider making real, detailed “worst case scenario planning” a priority. Take the time to summarize and implement the lessons learned during COVID-19 to create a guidebook for future public health or other emergencies while the events are still fresh in your mind.

• Plan for Increased Digital Interaction: In-person interactions between patients and clients and healthcare providers, customer service representatives, and more was already rapidly decreasing prior to the onset of the pandemic. The public health measures put in place to slow the spread of the disease taught us that video-conferencing and other forms of remote access can work…and work well. Like the majority of industries, life sciences companies need to find ways to integrate digital interaction into their daily operations and long-term business models.

• Evaluate Information Technology: What used to be an appropriate IT function will likely prove to be inadequate in a more digital, post-COVID world. With video-conferencing and other interactive applications now in use on a much wider scale, stricter cybersecurity measures need to be deployed as quickly as possible. Breaches and vulnerabilities have already been exposed early due to the increased use of these collaborative apps. Systematic IT strategies to address these are in order.

• Analyze Your Supply Chain: Commerce has had access to a global marketplace for at least 20 years. Despite the significant savings often realized by businesses when securing products from other countries, prepare for that to possibly change in a post-COVID environment. On the heels of “supply chain repatriation” activity in Europe, there is a bill currently in front of the US Senate that would provide incentives for companies to secure needed products—including medicinal devices and medical supplies so important to the life sciences industry—without going outside the country.

• Adjust for Pipeline Delays: The pandemic has resulted in significant disruptions to the typical schedule for the testing, approval, and subsequent launch of biopharmaceuticals. Clinical trials already in progress have been stopped or postponed. Fewer patients are enrolling in the small number of trials that are still moving forward, and the changes in Food and Drug Administration (FDA) policies and procedures driven by the need to comply with physical distancing and other public health measures are also resulting in considerable delays to market.

Life sciences companies are dealing with the same “unprecedented” crisis as the rest of the business sector, but a review of the last three decades would indicate that the industry has some unique characteristics that will help it survive economically while contributing significantly to the solution the world is waiting for.

Posted on by

BaneBio: Working Toward a Sustainable Maryland

At BaneBio, we’re proud to say that every day is Earth Day. Our membership in The Maryland Green Registry is one important way that we have stated our commitment to strong, proactive environmental management through sustainable policies with measurable results.

recycling of metal graph

Our Environmental Policy Statement

We strive to achieve good environmental practices and operate in a sustainable manner. Reducing our environmental impact and continually improving our environmental performance are integral to our business strategy, core values, and operating methods.

 We have pledged to:

  • Support and comply with the requirements of current environmental regulations.
  • Improve our environmental efforts by setting goals to reduce, reuse, and recycle to the best of our ability each year
  • Reduce material and energy waste, the production of material waste, and energy waste
  • Reuse or recycle as much of our waste as possible
  • Reduce the production of pollutants with respect of water, land, and air
  • Adequately train all staff on environmental codes of practice and our developed environmental program
  • Communicate the importance of good environmental practice to our customers, staff, and community

Our Environmental Team

The nine members of BaneBio’s environmental team work continually to discover new and different ways to communicate with our customers and the community about the importance of proper environmental practices. Each team member is empowered to strive for 100% recycling as a part of our daily business routine.

Our Annual Environmental Goals

Our management and environmental teams meet monthly to discuss ways to minimize our ecological impact during the course of our day-to-day operations. We have made a commitment to:

  • Recycle all components of equipment that have reached the end of their usable life
  • Reduce facility waste by 75%
  • Improve environmental efforts by placing multiple recycle bins around the office and warehouse
  • Encourage staff, customers, and the community to abide by current environmental regulations

Environmentally Preferable Products and Services

BaneBio’s core business is based on regenerating and extending the life of lab equipment that might otherwise be disposed of. If equipment reaches the end of its life, the parts are scrapped and recycled at the local scrapyard.

Environmentally Preferable Purchasing

BaneBio purchases copy paper, file folders, ink cartridges, note pads, markers, plastic cutlery, plates, can liners, and bathroom tissue that are classified either “green” or recycled.

Solid Waste Reduction and Reuse

We believe in reusing/recycling all types of packaging and office materials. In the warehouse, we reuse bubble wrap, fill cushioning, polyethylene-poly bags, cardboard boxes, and more. In the office, we reuse/recycle manila file folders, copy paper, cardstock, plastic ware, CDs, glassware, aluminum, desk accessories, and office chairs.

Recycling

Bane Bio recycles the warehouse and office supplies listed above when they cannot be reused. In addition, we recycle steel, stainless steel, aluminum, brass, and copper

The Maryland Green Registry has been an invaluable partner to BaneBio as we strive to develop, meet, and exceed our goals on the path to sustainability. BaneBio is proud to have done its part to help the Maryland Green Registry save more than $107 million annually through the proven, practical measures they have shared with their members.

Posted on by

Starting a Lab: Begin with the End in Mind

medical research lab

When starting a new lab, it’s wise to take a page out of Steven Covey’s landmark book from 1989, The 7 Habits of Highly Effective People and “begin with the end in mind.”
What Covey means here is this: before you start your project— in this case building or designing a new laboratory— think about what its function and purpose are going to be when you’re finished. Answering those questions will give you a roadmap for everything else.

For example, is this a research lab? A cell culture lab may need sanitized areas, autoclaves, freezers, and incubators. Analytical labs require efficient air-conditioning and controllable humidity. If used for teaching purposes, include a whiteboard, a projector, storage space for backpacks and supplies, and writing surfaces/desks.

Laboratory Equipment

This will likely be your biggest expense, so don’t take it lightly. Start with a detailed list of what you are going to fulfill the purpose of your new lab. Next, inventory what might already be available to you somewhere else in your current facilities. Decide if it makes sense for you to buy, rent, or lease. If you decide to buy, you can sometimes find discounts available only to new, start-up labs. Used lab equipment from a reputable dealer is also a great way to save money.

Layout

Once you have your vision and obtained the equipment needed to bring it to fruition, it’s time to lay out the physical plant. Start by laying out your lab into different “zones”, each with varying degrees and types of hazards. Allocate various functions into the different zones so that the equipment in each is easily accessible but does not impede the flow of traffic. Speaking of access, be sure that lab entry is restricted to only authorized personnel. And finally, be sure there are multiple exits to be sure everyone is as safe as possible in the event of an emergency such as fire or building evacuation.

Safety

In addition to basics like fire extinguishers, make sure you have fire blankets, emergency showers (with easy-reach handles), eye-wash stations, gloves, masks, and any other task-specific safety equipment that might be needed. Require all staff to complete a compulsory safety training program that identifies potential hazards and appropriate procedures to address them.

Paperwork

There’s a lot of DIY involved in setting up a new lab, but there will also be some steps for which you’d be better served to consult a senior PI or mentor to make sure your start-up is in compliance. At the top of the list will likely be a HIRA (Hazard Identification and Risk Assessment). If your lab will be conducting tests on animals, you will need to obtain a license for animal testing and submit a research proposal to the applicable, regional regulatory bodies for approval. Depending on the type of reagents you use, you will also need to file forms with various regulatory agencies, especially if you use infectious agents or biological toxins.

Biosafety

Biosafety involves the measures taken when handling biological organisms/materials that are known to pose a threat to human health. Containment of the potentially hazardous organism or material in an emergency to reduce the number of exposures is critical. Your lab will need to demonstrate the availability and efficient implementation of both primary and secondary barriers.

Posted on by

How To Choose the Right Medical Freezer

When you work in a field where consistency and accuracy are the foundation for meaningful results, it’s crucial to have the right tools for every task. Your equipment needs to do precisely what you need it to do the first time, every time, so that you and your staff are free to focus on your work with confidence.

So when it comes to buying a new freezer for your lab, finding a model that both meets your needs and provides consistent performance is crucial. And no matter how meticulously you have shopped for a household appliance in the past, finding the best commercial grade medical freezer is far more complicated. Specific requirements of commercial laboratory freezers include the abilities to:

  • Maintain a specific temperature consistently.
  • Reach an especially cold temperature in order to keep specific types of medical and laboratory samples fresh.
  • Tell users when the freezer temperature falls out of acceptable range.
  • Provide reliable durability to avoid the costs and consequences of ruined samples or medications.

Because an industrial freezer in a research laboratory or medical practice must meet more stringent requirements, expect the cost to reflect that. The cost is high but what’s at stake— including the accuracy of your results and potential damage to your lab’s good reputation— is far higher. So before you start shopping, review our Guide to get a solid idea of the options that should factor in to your decision about which industrial freezer to buy for your lab, pharmacy, or research facility.

Common Uses for Medical Freezers

A finely calibrated, high quality freezer for your healthcare facility, medical practice, pharmacy, or research laboratory will have specialized features that ensure that sensitive items remain viable including:

  • Vaccines, which must be stored according to CDC guidelines
  • Medications that require a consistent temperature for storage.
  • Chemicals that may be either ruined or compromised if not stored within a specific temperature range.
  • Medical laboratory samples and donations, such as blood, plasma, and bone marrow.
  • Sensitive research samples and material, such as biological research samples of tissue or cells.

Types of Medical & Lab Freezers

There are four main types of medical freezers for your consideration:

  1. Upright Medical Freezer. One of the common types of medical freezers, upright models come in a variety of sizes. From countertop for the smallest operations with very limited storage, to full sized units equipped to handle the storage needs of the largest research facilities and hospitals, upright medical freezers can be configured internally using movable shelves to suit the types of storage you need.
  2. Undercounter Medical Freezer. Typically on the smaller side, undercounter or “built-in” freezers can be made to fit seamlessly into the space available without taking up valuable floor space. To allow for proper ventilation, these undercounter units utilize forward-facing vents. This feature may result in a higher upfront cost for installation, but certain models are available that do not require professional installation.
  3. Chest Medical Freezer. Similar to the large, top-opening “deep freezers” found in residential settings, a commercial chest freezer offers a lot of storage space. Despite its significant volume, keep in mind that a commercial chest freezer will not have the shelving upright models have that allow for orderly organization and easier access. Some have alarm systems to alert users if the temperature changes, as well as digital temperature displays and doors that lock.
  4. Ultra-Low Temperature Medical Freezers. If the materials you are storing require especially low temperatures, you will likely need an ultra-low temperature freezer. Designed to reach temperatures as low as -85°, an ultra-low temperature freezer is ideal for storing sensitive materials that require extremely low temperatures that must be reliably, certifiably, and consistently maintained. These models fit the bill for power and consistency, but they also use a lot of energy to maintain those ultra-low temperatures– you will likely see this reflected in your energy bill.

Purchasing Considerations

Chances are you’re coming to this purchasing process with at least a basic idea of what options your lab freezer should have to meet your needs. To make sure you choose the best freezer for your facility, we’ve listed out a few important factors that should be considered while browsing your options.

  1. Size.  One of your most important decisions involves balancing the amount and type of storage you need with the amount of space you have to dedicate to the freezer. Upright units take up moderate floor space, and often can be custom-configured using the flexible shelving included— providing easier, more organized access to smaller items. If floor space isn’t an issue, and you typically store larger items that are readily visible and accessible without the use of shelves, a chest medical freezer may be the right option for you. You will also want to keep in mind your potential storage needs when your business grows. Purchasing a small freezer now that barely meets your storage needs may save you money today, but will ultimately prove falsely economical if you need to buy a second unit in the near future when your storage needs expand. Selecting a larger model initially with “room to grow” will likely cost a bit more initially, but that extra cost will be worth it if the larger freezer is better suited for your lab long-term.
  2. Temperature. With the exception of “ultra-low” freezers designed to maintain a consistent temperature down to as low as -86°, most medical freezers offer temperature ranges between -18° and -25°— which is comparable to residential appliances. But don’t be misled. Compared to home freezer units, medical freezers provide temperatures that are far more precise, consistent, and sustainable. In addition, most medical freezers are equipped with important safety features— like digital thermostat displays on the outside of the freezer, and alarms that alert users when there’s been an unexpected change in temperature— to help ensure your materials are being stored at the correct temperature at all times.
  3. Cost. The amount of money you have to spend can place some restrictions on the type of medical freezer you can afford. Start by analyzing precisely what your needs are for storage, the space you have to dedicate to the freezer, and the budget you have to work with.
  4. Energy Efficiency. To conserve energy and manage costs involved, look for a lab freezer that is Energy Star-rated. You may need to consult the most recent EPA guidelines for Energy Star ratings for laboratory-grade refrigeration and freezers, but the extra research will be well worth it.

Features to Look For:

  1. External Digital Thermometer. Having a way to monitor your medical freezer’s internal temperature without opening the door and releasing cold air is important. A digital thermometer on the outside of the unit will allow you to easily view the temperature within the unit without opening the door.
  2. Lock. A lock will help keep out people who don’t have authorization to access the contents inside and minimize the frequency in which the freezer is opened. This is especially important in the case of some medications and chemicals.
  3. Glass Doors. See-through doors allow users to assess the contents without having to open the door.
  4. Combo Refrigerator/Freezer. Think about what your storage needs are. Does it make sense to invest in a tandem unit? You may find a refrigerator/freezer combo costs less and uses space more efficiently than buying the units separately.
  5. Temperature Alarm. Selecting a model that has an alarm that will alert you should the unit’s internal temperature change due to an electrical outage, malfunction, or user error will do more than any other feature to preserve the integrity your stored items.

Brands to Watch

  • American BioTech. A major player in the lab equipment and medical supplies arena with a good reputation for quality and service, American BioTech offers a wide selection of freezers in various sizes and designs. In addition to being reliable and solidly built, American BioTech’s line of medical freezers typically feature door locks and temperature alarms. They most often come with a warranty for parts and labor, which further backs up their reputation for reliability.
  • Like many brands included on this list, EdgeStar also deals in residential appliances as well as products for the medical and commercial space. Currently, the selection of medical equipment and supplies from EdgeStar is more limited than its counterparts, but its products have a good reputation for quality and reliability, and are receiving excellent user reviews.
  • Nor-Lake. Looking for a wide selection of medical freezers, including ultra-low temperature models specifically designed to store plasma? Nor-Lake is a great place to start. Their lab freezers are often energy-efficient, including special features like audio and visual temperature alarms and digital LED temperature displays. This is a growing company with a solid reputation for quality and reliability with an increasing number of satisfied users.
  • So-Low. Also a familiar name in lab and medical equipment, So-Low offers a wide range of lab freezers that can be used for various specialized purposes. Their freezers go through extensive testing to ensure they meet the exacting requirements of a medical environment, and most come with warranties to back that up.
  • Much like EdgeStar, this brand is better known for residential appliances, including a wide selection of refrigerators and freezers. On the commercial side, Summit has a moderate selection of medical freezers in various sizes that offer reliable and consistent temperature control and an array of special features such as temperature displays and locks.

When it comes to the performance of your new or used lab equipment— especially your freezer— the stakes are high. If your freezer malfunctions or breaks down, you may be facing the loss of important medical samples, blood or tissue that others have donated, or the credibility of the research you and your team have been working on. Choose carefully! Make sure you know precisely what your storage needs will be. Balance these needs against the space you have available for the freezer unit. Consider your growth needs, and by all means, go with a brand that has a solid reputation.